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Insulin Aspart PI Insulin Aspart Injection HIGHLIGHTS OF PRESCRIBING INFORMATION Insulin aspart is stable in infusion fluids such as 0.9% • Fluid retention and heart failure with concomitant use of thiazolidinediones (TZDs): Observe for signs and symptoms of These highlights do not include all the information sodium chloride. • Individualize and adjust the dosage of insulin aspart based heart failure; consider dosage reduction or discontinuation if needed to use insulin aspart safely and effectively. heart failure occurs (5.7). See full prescribing information for insulin aspart. on route of administration, the individual’s metabolic needs, blood glucose monitoring results and glycemic control goal • Hyperglycemia and Ketoacidosis Due to Insulin Pump Device Insulin Aspart Injection, for subcutaneous or (2.4). Malfunction: Monitor glucose and administer insulin aspart by intravenous use • Dosage adjustments may be needed with changes in physical subcutaneous injection if pump malfunction occurs (5.8). Initial U.S. Approval: 2000 activity, changes in meal patterns (i.e., macronutrient content ——— ADVERSE REACTIONS ——— ——— RECENT MAJOR CHANGES ——— or timing of food intake), changes in renal or hepatic function Adverse reactions observed with insulin aspart include: Dosage and Administration (2.1)-----------------------------------12/2018 or during acute illness (2.4). hypoglycemia, allergic reactions, local injection site reactions, Dosage and Administration (2.2) ----------------------------------11/2019 ——— DOSAGE FORMS AND STRENGTHS ——— lipodystrophy, rash, and pruritus (6). Warnings and Precautions (5.2) -----------------------------------11/2019 Each presentation contains 100 Units of insulin aspart per mL To report SUSPECTED ADVERSE REACTIONS, contact (U-100) Novo Nordisk Pharma, Inc. at 1-800-727-6500 or FDA ——— INDICATIONS AND USAGE ——— • 10 mL multiple-dose vial (3) at 1-800-FDA-1088 or www.fda.gov/medwatch. • Insulin aspart is rapid acting human insulin analog indicated to • 3 mL single-patient-use PenFill® cartridges for the ——— DRUG INTERACTIONS ——— improve glycemic control in adults and children with diabetes ® mellitus (1). 3 mL PenFill cartridge device (3) • Drugs that may increase the risk of hypoglycemia: antidiabetic • 3 mL single-patient-use Insulin Aspart FlexPen® (3) agents, ACE inhibitors, angiotensin II receptor blocking ——— DOSAGE AND ADMINISTRATION ——— agents, disopyramide, fibrates, fluoxetine, monoamine ——— CONTRAINDICATIONS ——— • See Full Prescribing Information for important administration oxidase inhibitors, pentoxifylline, pramlintide, propoxyphene, • During episodes of hypoglycemia (4). and dosage instructions (2.1, 2.2, 2.3, 2.4, 2.5). salicylates, somatostatin analog (e.g., octreotide), and • Hypersensitivity to insulin aspart or one of its excipients. • Subcutaneous injection (2.2): sulfonamide antibiotics (7). Inject subcutaneously within 5-10 minutes before a meal ——— WARNINGS AND PRECAUTIONS ——— • Drugs that may decrease the blood glucose lowering effect: into the abdominal area, thigh, buttocks or upper arm. • Never share an Insulin Aspart FlexPen®, PenFill® cartridge or atypical antipsychotics, corticosteroids, danazol, diuretics, estrogens, glucagon, isoniazid, niacin, oral contraceptives, Rotate injection sites within the same region from one PenFill® cartridge device between patients, even if the needle phenothiazines, progestogens (e.g., in oral contraceptives), injection to the next to reduce risk of lipodystrophy and is changed (5.1). protease inhibitors, somatropin, sympathomimetic agents localized cutaneous amyloidosis. • Hyperglycemia or hypoglycemia with changes in insulin (e.g., albuterol, epinephrine, terbutaline), and thyroid Should generally be used in regimens with an regimen: Make changes to a patient’s insulin regimen (e.g., hormones (7). intermediate- or long-acting insulin. insulin strength, manufacturer, type, injection site or method • Drugs that may increase or decrease the blood glucose • Continuous Subcutaneous Infusion (Insulin Pump) (2.2): of administration) under close medical supervision with increased frequency of blood glucose monitoring (5.2). lowering effect: alcohol, beta-blockers, clonidine, lithium salts, Administer by continuous subcutaneous infusion using an and pentamidine (7). • Hypoglycemia: May be life-threatening. Increase frequency insulin pump in a region recommended in the instructions • Drugs that may blunt the signs and symptoms of from the pump manufacturer. of glucose monitoring with changes to: insulin dosage, co-administered glucose lowering medications, meal hypoglycemia: beta-blockers, clonidine, guanethidine, and Rotate the injection sites within the same region from one reserpine (7). injection to the next to reduce the risk of lipodystrophy and pattern, physical activity; and in patients with renal or hepatic localized cutaneous amyloidosis. impairments and hypoglycemia unawareness (5.3). ——— USE IN SPECIFIC POPULATIONS ——— Change the Insulin aspart in the reservoir at least every 6 • Medication Errors: Accidental mix-ups between insulin • Pediatric: Has not been studied in children with type 2 days. products can occur. Instruct patients to check insulin labels diabetes. Has not been studied in children with type 1 diabetes Change the infusion set and the infusion set insertion site before injection (5.4). <2 years of age (8.4). • Hypersensitivity reactions: Severe, life-threatening, at least every 3 days. See 17 for PATIENT COUNSELING INFORMATION and generalized allergy, including anaphylaxis, may occur. Do not mix with other insulins or diluents in the pump. FDA approved patient labeling. Discontinue insulin aspart, treat, and monitor, if indicated • Intravenous Administration (2.2): (5.5). Revised: 11/2019 Dilute insulin aspart to concentrations from 0.05 unit/ • Hypokalemia: May be life-threatening. Monitor potassium mL to 1 unit/mL insulin aspart in infusion systems using levels in patients at risk of hypokalemia and treat if indicated polypropylene infusion bags. (5.6). FULL PRESCRIBING INFORMATION: CONTENTS* 6 ADVERSE REACTIONS 14 CLINICAL STUDIES 1 INDICATIONS AND USAGE 6.1 Clinical Trial Experience 14.1 Overview of Clinical Studies 6.2 Immunogenicity 14.2 Clinical Studies in Adult and Pediatric Patients with 2 DOSAGE AND ADMINISTRATION Type 1 Diabetes and Subcutaneous Daily Injections 2.1 Important Administration Instructions 6.3 Post Marketing Experience 7 DRUG INTERACTIONS 14.3 Clinical Studies in Adults with Type 2 Diabetes and 2.2 Route of Administration Subcutaneous Daily Injections 2.3 Dosage Information 8 USE IN SPECIFIC POPULATIONS 14.4 Clinical Studies in Adults and Pediatrics with Type 2.4 Dosage Adjustment Due to Drug Interactions 8.1 Pregnancy 1 Diabetes Using Continuous Subcutaneous Insulin 2.5 Instructions for Mixing with Other Insulins 8.2 Lactation Infusion (CSII) by External Pump 3 DOSAGE FORMS AND STRENGTHS 8.4 Pediatric Use 14.5 Clinical Studies in Adults with Type 2 Diabetes Using Continuous Subcutaneous Insulin Infusion 4 CONTRAINDICATIONS 8.5 Geriatric Use 8.6 Renal Impairment (CSII) by External Pump 5 WARNINGS AND PRECAUTIONS 8.7 Hepatic Impairment 16 HOW SUPPLIED/STORAGE AND HANDLING ® ® 5.1 Never Share an Insulin Aspart FlexPen , PenFill ® 10 OVERDOSAGE 16.1 How Supplied Cartridge, or PenFill Cartridge Device Between 16.2 Recommended Storage Patients 11 DESCRIPTION 17 PATIENT COUNSELING INFORMATION 5.2 Hyperglycemia or Hypoglycemia with Changes in 12 CLINICAL PHARMACOLOGY Insulin Regimen 12.1 Mechanism of Action * Sections or subsections omitted from the full prescribing 5.3 Hypoglycemia 12.2 Pharmacodynamics information are not listed. 5.4 Hypoglycemia Due to Medication Errors 12.3 Pharmacokinetics 5.5 Hypersensitivity and Allergic Reactions 5.6 Hypokalemia 13 NONCLINICAL TOXICOLOGY 5.7 Fluid Retention and Heart Failure with Concomitant 13.1 Carcinogenesis, Mutagenesis, Impairment of Use of PPAR-gamma Agonists Fertility 5.8 Hyperglycemia and Ketoacidosis Due to Insulin 13.2 Animal Toxicology and/or Pharmacology Pump Device Malfunction 1 Insulin Aspart Injection 2 FULL PRESCRIBING INFORMATION 2.5 Instructions for Mixing with Other Insulins 5.5 Hypersensitivity and Allergic Reactions 1 INDICATIONS AND USAGE Insulin aspart Insulin aspart may be mixed with NPH insulin Severe, life-threatening, generalized allergy, including anaphylaxis, can Insulin aspart is a rapid acting human insulin analog indicated to improve subcutaneous injection preparations ONLY. occur with insulin products, including insulin aspart. If hypersensitivity glycemic control in adults and children with diabetes mellitus. route • If insulin aspart is mixed with NPH reactions occur, discontinue insulin aspart; treat per standard of care and insulin, draw insulin aspart into the 2 DOSAGE AND ADMINISTRATION monitor until symptoms and signs resolve [see Adverse Reactions (6)]. syringe first and inject immediately Insulin aspart is contraindicated in patients who have had hypersensitivity 2.1 Important Administration Instructions after mixing. reactions to insulin aspart or one of the excipients [see Contraindications • Always check insulin labels before administration [see Warnings and Insulin aspart continuous Do NOT mix insulin aspart with any other Precautions (5.4)]. subcutaneous infusion insulin. (4)]. • Inspect insulin aspart visually before use. It should appear clear and route (Insulin Pump) 5.6 Hypokalemia colorless. Do not use insulin aspart if particulate matter or coloration is 3 DOSAGE FORMS AND STRENGTHS All insulin products, including
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